Atrial FibrillationDURABLE-INCT02878213
DURABLE-I Study: Dielectric Unravelling of Radiofrequency ABLation Effectiveness
A study testing D700 System in people with Atrial Fibrillation, run by EPD Solutions, A Philips Company at 1 site in Russia.
Trial summary
The purpose of this study is to evaluate real-time gap detection using EPD D700 dielectric sensing compared with customary electrical isolation tests and Adenosine infusion at the end of the procedure. Furthermore, safety, usability and clinical applicability of the system for guided AF ablation will be confirmed. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- D700 System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteRussia
- Study dates
- 23 Sep 2016to 16 Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients, age ≥ 18 and ≤ 80 years.
- Paroxysmal atrial fibrillation (PAF)
- Able to provide written informed consent form to participate in the study, prior to any study related procedures.
- Able and willing to comply with the study protocol requirements.
- A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days.
Who cannot join
- Any planned surgical or endovascular intervention within 30 days before or after the index procedures.
- Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint.
- Previous AF ablation therapy.
- Clinical evidence of active coronary ischemia, significant Valvular heart disease, or hemodynamically significant congenital cardiac abnormality.
- Patient had experienced myocardial infarction (MI), stroke (CVA) or transient ischemic attack (TIA) or other neurological disturbances.
- Patient has a pacemaker.
Show all 10Show fewer
- Thrombi detected in the heart.
- Life expectancy less than 12 months.
- Known severe renal insufficiency.
- Known allergy to Iodine.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Arrhythmia Department and Electrophysiology Laboratory, State Research Institute of Circulation Pathology
Novosibirsk, 630055
About this study
The purpose of this study is to evaluate real-time gap detection using EPD D700 dielectric sensing compared with customary electrical isolation tests and Adenosine infusion at the end of the procedure. Furthermore, safety, usability and clinical applicability of the system for guided AF ablation will be confirmed.
Read the detailed description
Prospective, single-center, non-randomized, non-blinded, open label, and single arm study.
All procedures will be performed under CARTO-3 guidance for the treatment of atrial fibrillation (AF). The EPD D700 system will be used in-tandem, to record pre-, during and immediate post-ablation tissue characteristics and compute likelihood of lesion transmurality and permanency. Additionally, D700 system safety, feasibility, usability and clinical applicability will be documented.
The entire procedure will be conducted as customary, using standard and approved off-the-shelf equipment (body surface electrodes, diagnostic and irrigated ablation catheters, RF generator and recording system), in a completely clinically independent manner from the EPD D700 system. The physician will neither use nor rely on any of the D700 system output for clinical decision making and will be blinded to the D700 lesion assessment forecasts. After 30 days following the initial procedure, a repeated procedure will be performed for gap detection and its results will be correlated with the D700 predictions.
- Conditions
- Atrial Fibrillation
- Being tested
- D700 System
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D700 SystemDevice
Atrial Fibrillation Ablation Procedure
| Study group | Role | What they receive |
|---|---|---|
| D700 System | Experimental | Patients referred to catheter-based Atrial-Fibrillation (AF) ablation procedure therapy comprising of Pulmonary Veins Isolation (PVI). Receives: Device: D700 System |
What is being measured
The primary outcome is the main question the study is designed to answer.
ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy
ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy. All patients underwent PVI at index procedure. The physicians were blinded to the D700 (KODEX-EPD) ETA function pairwise real-time lesion assessment readings.
All patients were restudied at 1-mont, and ETA reading, which is the number of gaps as predicted by the system, were compared to the actual gaps as validated in the second procedure after one month.
Measured: 30 days
1-month Patient Analysis
ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study start23 Sep 2016
- Primary completion25 Jan 2017
- Study completion16 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- EPD Solutions, A Philips Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Evgeny A Pokushalov, MD, PhD, Principal investigator, State Research Institute of Circulation Pathology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878213
- Sponsor's protocol ID
- CLN-D700-004
- Acronym
- DURABLE-I
- Status last verified
- May 2018
- First submitted
- 28 Jul 2016
- Last updated
- 18 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DURABLE-I Study: Dielectric Unravelling of Radiofrequency ABLation Effectiveness
- ClinicalTrials.gov ID
- NCT02878213
- Acronym / sponsor ID
- DURABLE-I / CLN-D700-004
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- EPD Solutions, A Philips CompanyIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2016 (actual)
- Primary completion
- 25 Jan 2017 (actual)
- Study completion
- 16 Nov 2017 (actual)
- First posted
- 25 Aug 2016 (estimated)
- Results
- Posted 18 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate real-time gap detection using EPD D700 dielectric sensing compared with customary electrical isolation tests and Adenosine infusion at the end of the procedure. Furthermore, safety, usability and clinical applicability of the system for guided AF ablation will be confirmed.
Detailed description
Prospective, single-center, non-randomized, non-blinded, open label, and single arm study.
All procedures will be performed under CARTO-3 guidance for the treatment of atrial fibrillation (AF). The EPD D700 system will be used in-tandem, to record pre-, during and immediate post-ablation tissue characteristics and compute likelihood of lesion transmurality and permanency. Additionally, D700 system safety, feasibility, usability and clinical applicability will be documented.
The entire procedure will be conducted as customary, using standard and approved off-the-shelf equipment (body surface electrodes, diagnostic and irrigated ablation catheters, RF generator and recording system), in a completely clinically independent manner from the EPD D700 system. The physician will neither use nor rely on any of the D700 system output for clinical decision making and will be blinded to the D700 lesion assessment forecasts. After 30 days following the initial procedure, a repeated procedure will be performed for gap detection and its results will be correlated with the D700 predictions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| D700 System | Experimental | Device: D700 SystemPatients referred to catheter-based Atrial-Fibrillation (AF) ablation procedure therapy comprising of Pulmonary Veins Isolation (PVI). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients, age ≥ 18 and ≤ 80 years.
- Paroxysmal atrial fibrillation (PAF)
- Able to provide written informed consent form to participate in the study, prior to any study related procedures.
- Able and willing to comply with the study protocol requirements.
- A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days.
Key exclusion criteria (10 listed)
- Any planned surgical or endovascular intervention within 30 days before or after the index procedures.
- Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint.
- Previous AF ablation therapy.
- Clinical evidence of active coronary ischemia, significant Valvular heart disease, or hemodynamically significant congenital cardiac abnormality.
- Patient had experienced myocardial infarction (MI), stroke (CVA) or transient ischemic attack (TIA) or other neurological disturbances.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D700 SystemAtrial Fibrillation Ablation Procedure | Device | D700 System |
Primary outcome
ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy
Time frame: 30 days
ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy. All patients underwent PVI at index procedure. The physicians were blinded to the D700 (KODEX-EPD) ETA function pairwise real-time lesion assessment readings. All patients were restudied at 1-mont, and ETA reading, which is the number of gaps as predicted by the system, were compared to the actual gaps as validated in the second procedure after one month.
1-month Patient Analysis
Time frame: 30 days
ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evgeny A Pokushalov, MD, PhD principal investigator
State Research Institute of Circulation Pathology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D700 System in people with Atrial Fibrillation, run by EPD Solutions, A Philips Company at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.